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U.S. Department of Health and Human Services

Class 2 Device Recall NonLocking Screw

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  Class 2 Device Recall NonLocking Screw see related information
Date Initiated by Firm April 06, 2018
Date Posted June 07, 2018
Recall Status1 Terminated 3 on June 30, 2021
Recall Number Z-2123-2018
Recall Event ID 79819
510(K)Number K140876  
Product Classification Plate, fixation, bone - Product Code HRS
Product Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010)
b) D 3.2MM X 12MM (002-D-32012)
c) D 3.2MM X 14MM (002-D-32014)
d) D 3.2MM X 16MM (002-D-32016)
e) D 3.2MM X 18MM (002-D-32018)
f) D 3.2MM X 20MM (002-D-32020)
g) D 3.2MM X 22MM (002-D-32022)
h) D 3.2MM X 24MM (002-D-32024)
i) D 3.2MM X 26MM (002-D-32026)
j) D 3.2MM X 28MM (002-D-32028)
k) D 3.2MM X 30MM (002-D-32030)
l) D 3.2MM X 32MM (002-D-32032)
m) D 3.2MM X 34MM (002-D-32034)
n) D 3.2MM X 36MM (002-D-32036)
o) D 3.2MM X 38MM (002-D-32038)
p) D 3.2MM X 40MM (002-D-32040)
q) D 3.2MM X 42MM (002-D-32042)
r) D 3.2MM X 44MM (002-D-32044)
s) D 3.2MM X 46MM (002-D-32046)
t) D 3.2MM X 48MM (002-D-32048)
u) D 3.2MM X 50MM (002-D-32050)
Code Information (UDI)/Lot: a) (18056099645959) B1082246; b) (18056099645966) B1075836; c) (18056099645973) B1084806; d) (18056099645980) B1089892; e) (18056099645997) B1075845; f) (18056099646000) B1084797; g) (18056099646017) B1084792; h) (18056099646024) B1084799; i) (18056099646031) B1083858; j) (18056099646048) B1083859; k) (18056099646055) B1089891, B1195735; l) (18056099646062) B1195736, B1089882; m)(18056099646079) B1204992, B1083850; n) (18056099646086) B1083848, B1195699; o) (18056099646093) B1195732, B1089896; p) (18056099646109) B1204991, B1083642; q) (18056099646116) B1195739, B1083851; r) (18056099646123) B1204988, B1083637; s) (18056099646130) B1195733, B1089898; t) (18056099646147) B1195744, B1083838; u) (18056099646154) B1195730, B1071599, B1083853 
Recalling Firm/
Manufacturer		 Orthofix, Inc
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information Contact Gianluca Ricadona
469-742-2500
Manufacturer Reason
for Recall		 Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
FDA Determined
Cause 2		 Device Design
Action On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
Quantity in Commerce 1206
Distribution U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
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